Writing a 510(k) for FDA eSTAR Program

Adapting your approach to writing a 510(k) to accommodate the new eSTAR requirements is no easy task. The days of writing a creative submission that tells a story of development, safety, effectiveness and substantial equivalence with a beautifully orchestrated flow are over. The old 510(k) format will not readily fit into the eSTAR template. FDA’s eSTAR is an interactive PDF template for medical device 510(k), De Novo, and PMA submissions. It generates thousands of pages, includes hover-over pop-up JavaScript Windows instructions, and requires tens of attachments depending on your device complexity.

Use of eSTAR for submitting 510(k)s became mandatory for the industry beginning October 1, 2023. Which is also when eCopy became unavailable for 510(k)s. De Novo and Premarket Approval (PMA) will remain eligible for eSTAR on a volunteer basis.

Following are five tips to help you transition to using eSTAR.

Most of the elements outlined in the FDA guidance document titled ‘Format for Traditional and Abbreviated 510(k)’ are still present but in a prescribed format. In most cases, eSTAR asks specific questions and provides a limited number of choices as answers via dropdown menus or “select the appropriate box” checkmarks.

In other parts of the template, attachments are required. At least within the attachments, creative introductions can be added to help frame the story. The limited response options in the drop-down menus etc can be insufficient and stifle creative writing opportunities.

If this is your first time, be sure to register for a CDRH Portal account to send CDRH eSTAR premarket submissions online. This portal will allow you to track your submission.

Also, remember to submit your user fees at least two weeks in advance of sending in your eSTAR 510(k). This allows the FDA enough time to process your payment. If you are new to paying user fees and don’t understand the process, the FDA has created this handy guidance document to support you:

• User Fees and Refunds for Premarket Notification Submissions (510(k)s) – Guidance for Industry and Food and Drug Administration Staff

Take time to explore the FDA eSTAR template to gain an understanding of what information and format each section entails. When you go into eSTAR, most fields for populating information are not visible until you begin making certain choices. For instance, one of the first things it asks is the type of submission: Traditional, Abbreviated or Special. Walk through the questions and provide answers to see what additional fields become visible to you. Create your own template outside of eSTAR accordingly.

It is highly recommended that you completely populate your own template before loading it into eSTAR. This is because eSTAR does not save an editable version of your submission. By taking the time to save your own fully populated template you can use it as a starting point for future submissions as a lot of the data may stay the same. Especially if the reason for the next submission is modifications to the existing cleared device.

FDA has been issuing upgrades, as newer versions of the template, about every couple of months.  When new versions are issued, older versions become obsolete, and you will no longer be able to upload them to eSTAR. It’s best to use your own template outside of eSTAR and only populate eSTAR when your 510(k) data is complete. Once signed as complete in eSTAR you cannot make any edits to attachments or the responses. Yes, you can provide additional information, but you cannot change what has been previously submitted.

FDA announced FY2024 FDA User Fees on July 28, 2023. This announcement included huge price increases of 56% for 510(k) $21,760 or $5,440 for small businesses.

FDA 510(k) Submission Fees 2024

View on FDA’s website

The eSTAR was developed with the purpose of streamlining and organizing the FDA’s review of premarket submissions. The eSTAR template creates submissions that are consistent by organizing the data in the same order each time and every submission answering the same direct questions. Overall, this should increase the FDA’s efficiency. However, the eSTAR format results in generating thousands of pages which is a significant increase from 510(k)s of the past.

The increase in pages in part contributes to the 56% increase across user fees. Time will tell if industry realizes benefits from eSTAR or if the benefits reside solely with the FDA.

Celegence provides regulatory strategy consulting and can help you navigate the complexities of FDA guidance interpretation and FDA interactions. If you need any assistance with eSTAR FDA submissions then reach out to us at info@celegence.com or contact us online for more information.